Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 38103 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Draft Guidance for 

Cilastatin Sodium; Imipenem; 

Relebactam.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398 and/or 

PSG-QUESTIONS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

draft guidance on a generic Cilastatin 

Sodium; Imipenem; Relebactam for 

injection. 

FDA initially approved new drug 

application 212819 RECARBRIO 

(cilastatin sodium; imipenem; 

relebactam for injection) in July 2019. 

We are now issuing a draft guidance for 

industry on generic cilastatin sodium; 

imipenem; relebactam for injection 

(‘‘Draft Guidance on Cilastatin Sodium; 

Imipenem; Relebactam’’). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on, among other things, the design of BE 

studies to support ANDAs for cilastatin 

sodium; imipenem; relebactam for 

injection. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 12, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15170 Filed 7–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 


lotter on DSK11XQN23PROD with NOTICES1
38104 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

June 1, 2021, through June 30, 2021. 

This list provides the name of 

petitioner, city and state of vaccination 

(if unknown then city and state of 

person or attorney filing claim), and 

case number. In cases where the Court 

has redacted the name of a petitioner 

and/or the case number, the list reflects 

such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 

injury, condition, or death described in 

the petition is due to factors unrelated 

to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

a. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition not set forth in the 

Vaccine Injury Table but which was 

caused by’’ one of the vaccines referred 

to in the Table, or 

b. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition set forth in the 

Vaccine Injury Table the first symptom 

or manifestation of the onset or 

significant aggravation of which did not 

occur within the time period set forth in 

the Table but which was caused by a 

vaccine’’ referred to in the Table. 

In accordance with Section 

2112(b)(2), all interested persons may 

submit written information relevant to 

the issues described above in the case of 

the petitions listed below. Any person 

choosing to do so should file an original 

and three (3) copies of the information 

with the Clerk of the United States 

Court of Federal Claims at the address 

listed above (under the heading FOR

FURTHER INFORMATION CONTACT), with a 

copy to HRSA addressed to Director, 

Division of Injury Compensation 

Programs, Healthcare Systems Bureau, 

5600 Fishers Lane, 08N146B, Rockville, 

Maryland 20857. The Court’s caption 

(Petitioner’s Name v. Secretary of HHS) 

and the docket number assigned to the 

petition should be used as the caption 

for the written submission. Chapter 35 

of title 44, United States Code, related 

to paperwork reduction, does not apply 

to information required for purposes of 

carrying out the Program. 

Diana Espinosa, 

Acting Administrator. 

List of Petitions Filed 

1. Kelly Hannon, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1304V 

2. Margaret Hoyt, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1305V 

3. Sarah Lopez, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1306V 

4. Lydia M. Goode, Greensboro, North 

Carolina, Court of Federal Claims No: 

21–1307V 

5. Jonathan Jarog, Chicago, Illinois, Court of 

Federal Claims No: 21–1308V 

6. Chad Adaway, Birmingham, Alabama, 

Court of Federal Claims No: 21–1311V 

7. John Buen, Boston, Massachusetts, Court 

of Federal Claims No: 21–1314V 

8. Robert Ben, Colorado Springs, Colorado, 

Court of Federal Claims No: 21–1315V 

9. David Plaut, Fort Collins, Colorado, Court 

of Federal Claims No: 21–1316V 

10. Ciara Johnson, Durango, Colorado, Court 

of Federal Claims No: 21–1317V 

11. Lindsay Walker on behalf of R.W., 

Aurora, Colorado, Court of Federal 

Claims No: 21–1318V 

12. Dana Hilden, Phoenix, Arizona, Court of 

Federal Claims No: 21–1321V 

13. Debbie L. Tice, Jackson, Mississippi, 

Court of Federal Claims No: 21–1322V 

14. Rhonda Boyd, Huntsville, Alabama, Court 

of Federal Claims No: 21–1323V 

15. Janice Walker, Ventura, California, Court 

of Federal Claims No: 21–1325V 

16. Mary Patricia Turner, Washington, 

District of Columbia, Court of Federal 

Claims No: 21–1327V 

17. Kara Mahuron, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1328V 

18. Estate of James Leroy Doebler, Deceased, 

Pascagoula, Mississippi, Court of Federal 

Claims No: 21–1331V 

19. Marlena Lloyd and Jeffrey Lloyd on 

behalf of C.L., Boston, Massachusetts, 

Court of Federal Claims No: 21–1332V 

20. Keith Montague, Boston, Massachusetts, 

Court of Federal Claims No: 21–1333V 

21. Daniel Murphy, Philadelphia, 

Pennsylvania, Court of Federal Claims 

No: 21–1334V 

22. Jennifer Huch and Lucas Huch on behalf 

of L.L.L.H., Bedford, Texas, Court of 

Federal Claims No: 21–1335V 

23. Michelle Gill on behalf of A.G., Phoenix, 

Arizona, Court of Federal Claims No: 21– 

1336V 

24. Thomas Burbank, Plainville, Connecticut, 

Court of Federal Claims No: 21–1337V 

25. Clifton Foley and Kelli Foley on behalf 

of N.F., Deceased, Burlington, North 

Carolina, Court of Federal Claims No: 

21–1338V 

26. Juanita Artman, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1340V 

27. Ramon K. Jusino and Ann M. Jusino on 

behalf of W.J., Staten Island, New York, 

Court of Federal Claims No: 21–1342V 

28. Nardia Thompson Harris, Nanuet, New 

York, Court of Federal Claims No: 21– 

1345V 

29. Michael Williamson, Murfreesboro, 

Tennessee, Court of Federal Claims No: 

21–1346V 

30. John Allain, Sulphur, Louisiana, Court of 

Federal Claims No: 21–1349V 

31. Jennifer Clark, Chattanooga, Tennessee, 

Court of Federal Claims No: 21–1350V 

32. Robert Silver, Shelby, North Carolina, 

Court of Federal Claims No: 21–1351V 

33. Kelsey Hamonds, Edgewood, Kentucky, 

Court of Federal Claims No: 21–1352V 

34. Mindy Schuehrer, Marie, Michigan, Court 

of Federal Claims No: 21–1353V 

35. Hortencia Torres, Annandale, Virginia, 

Court of Federal Claims No: 21–1356V 


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Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 38105 

36. Laurel Bennett, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1357V 

37. Marie Tully, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1358V 

38. Donna Fulbright, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1359V 

39. Jovonna Beyer, New York, New York, 

Court of Federal Claims No: 21–1362V 

40. Richard Munoz, Plant City, Florida, Court 

of Federal Claims No: 21–1369V 

41. Josephine Feitel, Georgetown, Texas, 

Court of Federal Claims No: 21–1370V 

42. Austin Reid, Louisville, Kentucky, Court 

of Federal Claims No: 21–1374V 

43. Elizabeth Fellows, Kansas City, Missouri, 

Court of Federal Claims No: 21–1378V 

44. Stephen R. Hunt, Athens, Ohio, Court of 

Federal Claims No: 21–1379V 

45. Raymond Milligan, Jr., Sulphur Springs, 

Texas, Court of Federal Claims No: 21– 

1382V 

46. Tina Paxson, Bloomington, Indiana, Court 

of Federal Claims No: 21–1383V 

47. Rashawnda L. Benton, Greensboro, North 

Carolina, Court of Federal Claims No: 

21–1384V 

48. Jerome Dacurawat, Alexandria, Virginia, 

Court of Federal Claims No: 21–1389V 

49. Krystal Kilgore, Morristown, Tennessee, 

Court of Federal Claims No: 21–1390V 

50. Jeffrey A. Ridenour, Lima, Ohio, Court of 

Federal Claims No: 21–1392V 

51. Lori Kathleen Ogden Erickson, Milton, 

Washington, Court of Federal Claims No: 

21–1395V 

52. Angela Saporito, Nutley, New Jersey, 

Court of Federal Claims No: 21–1398V 

53. Shawn Wilson-Blount, White Plains, New 

York, Court of Federal Claims No: 21– 

1400V 

54. Geeta Karra, Philadelphia, Pennsylvania, 

Court of Federal Claims No: 21–1402V 

55. Jonathan Charter, Manchester, 

Connecticut, Court of Federal Claims No: 

21–1404V 

56. Tammy Walden on behalf of J.F., 

Phoenix, Arizona, Court of Federal 

Claims No: 21–1406V 

57. Bruce A. Ades, Denver, Colorado, Court 

of Federal Claims No: 21–1407V 

58. Wendy O’Neil, Englewood, New Jersey, 

Court of Federal Claims No: 21–1410V 

[FR Doc. 2021–15223 Filed 7–16–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OMB #0990–0475] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before September 17, 

2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0475–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: ASPA COVID– 

19 Public Education Campaign 

Evaluation Surveys. 

Type of Collection: Extension. 

OMB No.: 0990–0475. 

Abstract: The Office of the Assistant 

Secretary for Public Affairs (ASPA), U.S. 

Department of Health and Human 

Services (HHS) is requesting an 

extension on a currently approved 

collection including two components: 1. 

COVID–19 Attitudes and Beliefs Survey 

(CABS), and 2. Monthly Outcome 

Survey (MOS). Throughout execution of 

the campaign, this information will 

primarily be used by ASPA to determine 

whether the campaign is having the 

intended impact on target audiences’ 

knowledge, attitudes, and beliefs as they 

relate to COVID–19, COVID–19 

vaccination, and adherence to 

preventative behaviors. It will also keep 

key stakeholders informed of the 

Campaign’s progress. Ultimately, the 

data will inform a thorough evaluation 

of the efficacy of the campaign and its 

impact on vaccine uptake. 

COVID–19 Attitudes and Beliefs Survey 

(CABS) 

The CABS is a longitudinal survey 

that will be fielded tri-annually to 4,000 

U.S. adults over two years (six waves) 

via NORC at the University of Chicago’s 

AmeriSpeak Panel. The survey will be 

fielded online, and each fielding period 

will last between 3 and 6 weeks. Those 

that respond to wave 1 of the survey 

will be recontacted in each wave, 

facilitating a comparison of COVID–19 

behavior change over time for a 

representative sample and evaluation of 

U.S. adults. Panel members selected to 

participate in the study will receive one 

pre-invitation postcard in the mail, one 

email invitation, and three email 

reminders to complete the survey in 

each wave. 

Monthly Outcome Survey (MOS) 

The MOS is a cross-sectional survey 

that will be fielded monthly to 5,000 

U.S. adults over two years (24 waves) 

via the Ipsos KnowledgePanel 5K 

Omnibus Survey. The survey will be 

fielded online, and each fielding period 

will last between 7 and 10 days. 

ANNUALIZED BURDEN HOUR TABLE

CABS MOS 

Hours to complete survey ........................................................................................................................................ 0.58 0.17 

Participants (per wave) ............................................................................................................................................ 4,000 5,000 

Number of waves (per year) .................................................................................................................................... 3 12 

Total respondents per year ..................................................................................................................................... 12,000 60,000 

Total burden hours per year .................................................................................................................................... 6,960 10,200 


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